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2018 Directory of Korean Pharmaceutical Industry

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2018 Directory of Korean Pharmaceutical Industry 2018 DIRECTORY OF KOREAN PHARMACEUTICAL INDUSTRY 2018 Table of Contents Greetings .................................................................................................................................................................... 004 Overview of the Korean Pharmaceutical Industry ........................................................................................... 005 Information of Pharmaceutical Companies ....................................................................................................... 009 - Regular Members - Associated Members KPBMA Member Company List ............................................................................................................................ 233 No Company Page No Company Page No Company Page No Company Page Elyson Pharmaceutical Co. Ltd. 068 Korea Otsuka Pharmaceutical Co.,Ltd. 131 Seoul Pharma Co.,Ltd. 188 Regular Members 28 56 84 29 GC Pharma 070 57 KOREA PHARMA CO., LTD. 133 85 SHIN POONG PHARM. CO., LTD. 190 A~G 30 Green Cross Cell Corporation 074 58 Korea Prime Pharm. Co., Ltd. 135 86 SINSIN Pharmaceutical Cp., Ltd. 192 1 Ahngook Pharmaceuticals Co., Ltd. 010 31 GUJU PHARM. CO. LTD. 077 59 KOREA UNITED PHARM.INC. 137 87 SK Chemicals Co., Ltd. 194 2 AJU PHARM CO., LTD. 012 60 Korea Vaccine 139 88 SS Pharm.Co.,Ltd. 196 3 Astellas Pharma Korea 014 H~K 61 KOREAN DRUG CO., LTD. 141 89 Suheung Capsule. Co., Ltd. 198 4 BC World Pharm. Co., LTD. 016 32 Hana Pharm Co., Ltd 079 62 KUKBO SCIENCE 143 90 Taejoon Pharmaceutical 200 5 Binex Co., Ltd. 018 33 HanAll Bio Pharma 081 63 Kukje Pharma Co., Ltd. 145 91 Taiguk Pharm. co., Ltd. 203 6 Boryung Pharmaceutical Co., Ltd. 020 34 HANDOK Inc. 083 64 Kwang Dong Pharmaceutical Co.,Ltd. 147 92 THERAGEN ETEX CO., LTD. 205 7 CHO-A PHARM.CO.,LTD. 022 35 Hankooksinyak Pharm. Co., Ltd. 086 65 Kyongbo Pharmaceutical Co., Ltd. 149 93 Union Korea Pharma Co., Ltd. 207 8 Chong Kun Dang Pharmaceutical Co. 024 36 HANLIM PHARM. CO., LTD. 088 66 Kyowa Hakko Kirin Korea Co., Ltd. 151 94 WHITE LIFE SCIENCE 209 9 CJHealthCare Corp. 027 37 Hanmi Pharm. Co., Ltd 090 67 Kyung Dong Pharm. Co., Ltd. 154 95 WhanIn Pharm Co., Ltd. 211 10 CMG Pharmaceutical Co., Ltd. 030 38 Han Wha Pharma Co., Ltd. 092 68 Kyung Nam Pharm. Co, Ltd 156 96 Won Kwang Pharm. Co., Ltd 213 11 CORESTEM Inc. 032 39 Hawon Pharmaceutical Corporation 094 97 WOORIDUL PHARMACEUTICAL LTD. 215 12 CTCBIO, Inc 034 40 Humedix Co., Ltd 096 M~Y 98 YOOYOUNG PHARMACEUTICAL 217 13 Daewoo Pharmaceutical Co., LTD 036 41 HUONS CO., LTD. 098 69 Medica Korea Co., Ltd. 158 99 Yuhan Corporation 219 14 Daebong LS Co., Ltd 038 42 Hyundai Pharm 100 70 MG Co., Ltd. 160 100 Yuyu Pharma., Inc. 221 15 DAE HWA PHARMACEUTICAL CO., LTD. 040 43 ICURE Pharmaceutical Inc 102 71 MOTHER'S PHARMACEUTICAL CO., LTD. 162 16 DAEWON Pharm. Co., Ltd 042 IKSU PHARMACEUTICAL CO., LTD. 104 Myung In Pharm. Co., Ltd. 164 44 72 Associated Members 17 Daewoong Pharmaceutical Co., Ltd. 044 45 ILDONG Pharmaceutical 107 73 Myung Moon Pharm. Co., Ltd. 166 18 DAI HAN PHARM. CO., LTD. 046 46 Ilsung Pharmaceuticals 109 74 Pharmbio Korea Co., Ltd 168 101 C&R Research Inc. 223 19 Daiichi Sankyo Korea 048 47 IL-YANG PHARM. CO., LTD. 111 75 PMG Pharm 170 102 CrystalGenomics, Inc. 225 20 Dalim BioTech Co., Ltd. 050 48 ISU Abxis Co., Ltd. 115 76 Richwood Pharmaceutical Co., Ltd. 172 103 GL PharmTech 227 21 DHP KOREA CO.,LTD. 052 49 JEIL Pharmaceutical Co., Ltd. 117 77 RP Bio 174 104 Medi Help line 230 22 DongKoo Bio&Pharma Co., Ltd. 055 50 JINYANG PHARM. Co., Ltd. 119 78 SamChunDang Pharm. Co., Ltd. 176 105 Pharmicell Co., Ltd. 231 23 Dongkook Pharmaceutical Co., Ltd. 057 51 JW Pharmaceutical Corporation 121 79 SAMA PHARM CO.,LTD. 178 24 Dongkwang Pharm. Co., Ltd. 059 52 KMS Pharm Co., Ltd. 123 80 Samik Pharm. Co., Ltd. 180 25 DONGWHA PHARM 061 53 Kolmar Korea Co.,Ltd. 125 81 Samil Pharm. Co., Ltd. 182 26 Dong-A ST(Science & Technology) 063 54 Kolon Pharma 127 82 Samjin Pharmaceutical Co., Ltd. 184 27 Dongsung Bio Pharm 066 55 Korea Arlico Pharm Co.,Ltd. 129 83 Samyang Biopharmaceuticals Corporation 186 2 2018 DIRECTORY OF KOREA PHARMACEUTICAL INDUSTRY 3 Greetings Overview of Korea’s Pharmaceutical Industry The market size of Korea’s pharmaceutical industry was USD 18.7 billion (as of 2016), making up 1.8% of approximately USD 1.1 trillion of the global pharmaceutical market, 1.2% of domestic GDP, and 4.3% of domestic manufacturing GDP. During the same period, domestic pharmaceutical production was USD 16.2 billion with export and import volumes accounting for USD 3.1 billion and USD 5.6 billion respectively, while domestic biopharmaceutical production was USD 1.73 billion, composing 9.2% of the domestic pharmaceutical market. As of 2016, there were 737 pharmaceutical companies who manufactured drug products. Of these, 367 manufactured Greetings from Korea Pharmaceutical and Bio-Pharma Manufacturers Association(KPBMA). This is Jung-Hee finished drug products, 204 manufactured drug substance, and 379 manufactured quasi drugs. Average revenue Lee, Chairman of the Directors Board. for publicly-traded pharmaceutical companies was USD 143 million, while 45 drug manufacturers generated USD 100 million or more in revenue and two manufacturers (Yuhan Corporation and Green Cross) recorded USD 1 Representing about 200 KPBMA member companies, I would like to express my sincere gratitude to all the billion or more (as of 2016). relevant readers who have interest in Korean pharmaceutical industry. Korean pharmaceutical companies are manufacturing quality medicines in compliance with ICH guidelines as Market Size (Unit: USD million, %) well as Pharmaceutical Affairs Act in Korea, in order to provide consumers with safe medicines. 2012 2013 2014 2015 2016 Market size (yearly growth rate) 17,060 (0.32) 17,648 (0.51) 18,395 (0.24) 16,992 (-0.69) 18,729 (12.94) As a result, the Ministry of Food and Drug Safety in Korea was able to join PIC/S in 2014, and became the Production 13,943 14,955 15,593 15,004 16,212 regular member of ICH in 2016. Export 2,077 2,128 2,416 2,946 3,121 Even with short history of 120 years, the Korean pharma industry was able to develop 29 new drugs(NCEs) Import 5,194 4,821 5,219 4,948 5,638 and as of the end of 2016, 82 incrementally modified drugs was developed by Korean pharma companies. As for Trade balance -3,117 -2,693 -2,803 -2,002 -2,517 clinical trials, Seoul is the best city of all city level in terms of the number of clinical trials. Biopharmaceuticals are other area that Korea is making real result. Following the recent trend, efforts to combine the advanced IT technology with new drug development is being made to usher in the 4th industrial revolution. Pharmaceutical Production and Quality The purpose of KPBMA Directory is to provide all related people from government, international organization and companies oversea with precise information regarding Korean pharma companies, thus to facilitate co- Management Capacities operation. Following the 2016 version, the KPBMA spared no efforts to list precise and recent information of each Equipped with advanced production and quality management capacities, Korean pharmaceutical manufacturers Korean company to highlight the strength of KPBMA member companies. are producing high quality pharmaceutical products. Additionally, efforts by domestic drug manufacturers to I hope that this directory can be helpful to promote the cooperation between Korean companies and readers. As improve Good Manufacturing Practice since the mid-2000’s, have allowed them to build cGMP facilities compliant for the KPBMA, we will make a promise to continue to update the information of the directory. with what are required by major countries such as the U.S. Thank you. As regulatory and quality management systems for drugs have improved with the sincere efforts of regulatory and private agencies, Korean drugs are now receiving great confidence as quality drugs not only from countries in Southeast Asia, Central and South America, but also from those in Europe and the U.S.. Furthermore, recent Jung-Hee Lee, Chairman of the Directors Board, KPBMA efforts by the Ministry of Food and Drug Safety (MFDS) to introduce Quality by Design (QbD) are leading Korea’s pharmaceutical industry to establish a production infrastructure that will meet the requirements that are expected of advanced countries. Korea also boasts world-class drug regulatory systems. The MFDS having joined the Pharmaceutical Inspection Cooperation Scheme (PIC/s) in May, 2014, is an international testament to the quality and management 4 2018 DIRECTORY OF KOREA PHARMACEUTICAL INDUSTRY 5 capabilities of Korean drug manufacturers, and has improved export conditions, including inspection exemptions product that obtained a marketing authorization from the US FDA in 2016. And it only took the world’s first of local drug manufacturing plants located in the PIC/s member nations. In addition, gaining Membership to the antibody biosimilar Remsima by Celltrion four years to exceed the USD 1 billion mark in aggregate export International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for revenues since its launch in 2013. Human Use (ICH) in November, 2016, has proved that the level of drug regulatory systems in Korea is on par with that of advanced countries, including the U.S., Japan and the EU, and has earned Korea elevated standing as one of the countries that is leading drug regulatory policies. This is expected to be a great stepping stone for Korea to Vigorous Global Market Entry advance in the global market as it will create favorable circumstances conducive to signing mutual agreements Korean drug manufacturers equipped with a global competitive edge in new drug development and drug with other national regulatory authorities and discussing exemptions required for gaining marketing approvals. formulation technologies, production management facilities and quality control practices are successfully entering markets around the world.
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